Quality Assurance Engineer

The Opportunity

This position supports Operations within the Cancer Diagnostics business. As a Quality Assurance Engineer, you will partner with Facilities, Service & Metrology, Process and Controls Engineering, Instrument Production, Reagent Manufacturing, Quality Control, and other areas of Operations. Depending on the assigned area, you will provide Quality oversight of products, materials, manufacturing and QC laboratory equipment and processes, instrumentation, facilities, utilities, and associated systems through qualification and validation, risk management, investigations, change control, and continuous improvement.

What You'll Work On

• Provide Quality Engineering oversight of manufacturing processes, instruments, equipment, facilities, utilities, and automated systems throughout their lifecycle, including qualification, validation, maintenance, calibration, and continuous improvement activities.
• Review and assess engineering and manufacturing changes for potential impacts to product quality, process performance, equipment qualification, validated state, and regulatory compliance.
• Lead or support investigations involving manufacturing deviations, nonconformances, out-of-specification results, equipment failures, calibration issues, and process or environmental monitoring excursions.
• Support risk assessments, support root-cause investigations, and develop or evaluate corrective and preventive actions (CAPA) to address quality issues and drive sustainable improvements.
• Provide Quality Engineering oversight of design and technology transfer activities, including manufacturing readiness, equipment and process qualification, verification and validation, risk management, and implementation of new or modified products and processes into Operations.
• Partner with engineering and operational teams to evaluate process improvements, equipment modifications, automation and control system changes, and manufacturing or QC testing requirements.
• Review and approve applicable Quality Management System records, engineering documentation, qualification and validation records, investigations, and change controls to ensure compliance with established procedures and regulatory requirements.
• Exercise independent Quality Engineering judgment when evaluating technical issues, identifying compliance risks, and recommending appropriate actions to maintain product quality and process control.

Required Qualifications

• Bachelor's degree in a science or technical field; or an associate degree in a science or technical field plus two (2) years of relevant experience in lieu of a bachelor's degree.
• Three (3) or more years of experience in a manufacturing operations environment.
• One (1) or more years of experience applying quality principles and practices in an assigned area such as Design Transfer, Risk Management, or Manufacturing Quality.
• One (1) or more years of experience with process or test method validation, equipment qualification, or related quality engineering activities.
• Demonstrated ability to work in an FDA 21 CFR 820, ISO 13485, ISO 9001, and/or cGMP-structured environment.
• Ability to travel up to 15%, including possible overnight or weekend travel, and comply with applicable personal protective equipment requirements.
• Authorization to work in the United States without sponsorship and ability to perform the essential duties with or without accommodation.

Preferred Qualifications

• Three (3) or more years of experience in medical device, biotechnology, pharmaceutical, or other regulated manufacturing environments.
• Experience supporting manufacturing processes, equipment, instrumentation, facilities, utilities, or Quality Control operations.
• Knowledge of equipment qualification, process validation, test method validation, and associated risk management principles.
• Experience supporting calibration, preventive maintenance, environmental monitoring, or equipment lifecycle management programs.
• Familiarity with manufacturing automation, process controls, and computerized systems in regulated environments.
• Experience supporting design and technology transfer activities, manufacturing process improvements, or implementation of new equipment and processes.
• Experience with electronic Quality Management Systems (eQMS), Product Lifecycle Management (PLM), or equipment asset management systems.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant professional certification.